MyndMove FES System
MyndMove FES System (910200) is a Class II device made by Myndtec, Inc., cleared under FDA 510(k) K170564 on 30 Aug 2017 and listed in FDA GUDID since 11 Dec 2019 (UDI-DI 00692520102007), active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00692520102007 | Date11 Dec 2019 | StatusListed |
| United States | FDA 510(k)SESE | NumberK170564 | Date30 Aug 2017 | StatusActive |
Official records
- AccessGUDID record 00692520102007
- FDA 510(k) database K170564
Across registries
- FDA 510(k) K170564 decided 30 Aug 2017 Active
- FDA GUDID UDI-DI 00692520102007 listed 11 Dec 2019 Listed
Timeline
- Cleared FDA 510(k) K170564
- Listed FDA GUDID 00692520102007
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- MyndMove
- Generic name
- Neuromuscular transmission electrode
- Model / Ref / Catalog
- MyndMove FES System, 910200
- Primary DI / UDI-DI
- 00692520102007
- 510(k) Number
- FDA product code
- IPF, GZI
- GMDN term
- Neuromuscular transmission electrode
- Device class
- Class II
- Regulation number
- 890.5850, 882.5810
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Unsafe
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